BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 2213961 · Received August 17, 2011

    Report

    Report Number
    6000001-2011-19341
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, THIS PRODUCT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT A FOLFUSER LEAKED FROM THE TUBING NEAR THE FLOW RESTRICTOR DURING INFUSION. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL, WHICH CONTACTED THE PATIENT'S SKIN DUE TO THE LEAK AND "LIGHTLY SCORCHED" THE SKIN AROUND WHERE THE PORT WAS CONNECTED. THE SAMPLE IS NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11B030

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL